Placebo Procedure Research Articles

Seizure Risk Associated With the Use of Transcranial Magnetic Stimulation for Coma Recovery in Individuals With Disordered Consciousness After Severe Traumatic Brain Injury.

Repetitive Transcranial Magnetic Stimulation (rTMS) is emerging as a promising treatment for persons with disorder of consciousness (DoC) following traumatic brain injury (TBI). Clinically, however, there are concerns about rTMS exacerbating baseline seizure risk. To advance understanding of risks, this article reports evidence of DoC-TBI rTMS-related seizure risk. Acute and sub-acute hospitals. Persons in states of DoC 6.5months to 15years after TBI (n=20) who received active rTMS (n=17) or placebo rTMS (n=3). After completing placebo procedures, placebo participants completed active rTMS procedures. These 3 participants are included in the active group. Meta-analysis of data from 3 clinical trials; 2 within-subject, 1 double blind randomized placebo-controlled. Each trial used the same rTMS protocol, provided at least 30 rTMS sessions, and delivered rTMS to the dorsolateral prefrontal cortex. During each study's rTMS treatment phase, seizure occurrences were compared between active and placebo groups using logistic regression. After stratifying active group by presence/absence of seizure occurrences, sub-groups were compared using contingency chi-square tests of independence and relative risk (RR) ratios. Two unique participants experienced seizures (1 active, 1 placebo). Post seizure, both participants returned to baseline neurobehavioral function. Both participants received antiepileptics during remaining rTMS sessions, which were completed without further seizures. rTMS-related seizure incidence rate is 59 per 1000 persons. Logistic regression revealed no difference in seizure occurrence by treatment condition (active vs placebo) or when examined with seizure risk factors (P >.1). Presence of ventriculoperitoneal shunt elevated seizure risk (RR=2.0). Collectively, findings indicate a low-likelihood that the specified rTMS protocol exacerbates baseline seizure rates in persons with DoC after TBI. In presence of VP shunts, however, rTMS likely elevates baseline seizure risk and mitigation of this increased risk with pharmacological seizure prophylaxis should be considered.

Intermittent hypoxic preconditioning reduces the risk of peri- and postoperative complications during on-pump cardiac surgery

Aim. To assess the effect of intermittent hypoxic-hyperoxic exposures (IHHE) on the outcomes of on-pump cardiac surgery.Material and methods. This prospective, single-center, randomized, controlled study was conducted in 110 patients with heart valve defects and/or aortic pathology from the cardiac surgery clinic of the I. M. Sechenov First Moscow State Medical University. The total sample was randomly divided into a group of patients who underwent IHHE (n=66) and a control group of patients who underwent placebo procedures with ambient air (n=44). The frequency and structure of intra-and postoperative complications were analyzed within 30 days after surgery. The presence of cognitive impairment, as well as serum troponin I and lactate concentrations were analyzed before and after surgery.Results. Peri- and early postoperative complications such as cardiac death, non-fatal infarction and acute heart failure occurred significantly less frequently in patients treated with IHHE compared with placebo group (1,6% vs 16,7%, p=0,009; 1,6% vs 16,7%, p=0,009; 6,3% vs 33,3%, p<0,001, respectively). The median troponin I values 24 hours after surgery were 1,068 ng/ml (0,388-1,397 ng/ml) in the IHHE group and were significantly lower compared to the control group (1,980 ng/ml (1,068-3,239 ng/ml)). The serum lactate level after surgery was 1,8±0,7 mmol/l in the IHHE group and was significantly lower compared to the control group — 2,4±1,2 (p=0,05). Cognitive function, assessed by MOCA and MMSE tests, turned out to be significantly higher in patients who underwent a preoperative IHHE. No significant complications or serious adverse events were observed during the IHHE procedures.Conclusion. The use of individually adapted hypoxic preconditioning procedures reduces the incidence of peri- and postoperative complications, which is accompanied by a lower ischemia-reperfusion myocardial injury during artificial circulation with preservation of cognitive functions. IHHE procedures ramp up prehabilitation of patients referred for on-pump surgery of heart defects and aortic pathology.

The combined effect of transcutaneous electrical nerve stimulation and transcutaneous auricular vagus nerve stimulation on pressure and heat pain thresholds in pain-free subjects: a randomized cross-over trial

BackgroundTranscutaneous electrical nerve stimulation (TENS) is a non-invasive modality that utilizes electrical currents to modulate pain in populations with acute and chronic pain. TENS has been demonstrated to produce hypoalgesic effects in postoperative pain, fibromyalgia, knee osteoarthritis, and healthy subjects. Transcutaneous auricular vagus nerve stimulation (TaVNS) is a non-invasive modality that modulates the vagus nerve by stimulating its auricular branches. The effects of the combination of TENS and TaVNS on producing an analgesic response have not been studied. Considering that TENS and TaVNS both stimulate similar analgesic pathways but through different means of activation, we can hypothesize that a combination of both methods can produce a more pronounced analgesic response. Therefore, the objective of this study is to assess the hypoalgesic effect of a combination of TENS and TaVNS in pain-free subjects.Methods/designThe study will be a simple crossover design conducted at the University of Hartford. Subjects will be recruited from the University of Hartford population via oral communication, digital flyers, and posters on campus. Thirty participants will undergo two sessions in a crossover manner with one week in between. During one session, the participants will receive TENS with active TaVNS and the other session will be a placebo procedure (TENS with placebo TaVNS). The order of these sessions will be randomized. Importantly, the pressure pain threshold (PPT) and heat pain threshold (HPT) assessors will be blinded to the treatment category. For active TaVNS, a frequency of 25 Hz will be applied with a pulse duration of 200 µs. For placebo TaVNS, the intensity will be increased to a sensory level and then decreased to 0 mA. High-frequency TENS of 100 Hz will be applied in both sessions, with a pulse duration of 200 µsec, asymmetrical biphasic square waveform, and intensity of maximal tolerance without pain. TENS and TaVNS will be turned on for 30 min after a baseline measurement of outcomes. TENS and TaVNS will then be turned off, but the electrodes will remain on until completion of post-treatment assessment. Pressure pain threshold, heat pain threshold, blood pressure, oxygen saturation, and heart rate will be tested 4 times: Once pre-intervention, once during intervention, once immediately after the intervention, and once 15 min post-intervention. Statistical analysis of the data obtained will consider a significance level of p < 0.05.DiscussionThis study will provide evidence concerning the combined effects of TENS and TaVNS on pain threshold in pain-free participants. Based on the outcomes, a greater understanding of how TENS and TaVNS, when used in conjunction, can modulate pain pathways.Trial registrationClinicalTrials.gov NCT06361381. Registered on 09 April 2024.

The Role of Attention in Placebo and Nocebo Effects.

Although some existing models propose that attention may be crucially implicated in placebo/nocebo effects, empirical research on this aspect remains limited and scattered. This systematic review aims to provide an inclusive overview of studies that have either directly manipulated or assessed attention within the context of placebo and nocebo procedures so to gain a synthetized picture of the role of this variable in placebo/nocebo effects. Importantly, only studies in which attention represented a mechanism or mediator of the placebo/nocebo response, and not a primary outcome, were included. A systematic search was conducted across multiple databases, including PubMed, Scopus, PsycINFO, Web of Science, and Embase, to identify peer-reviewed studies. These studies were subjected to methodological evaluation and eligibility criteria for inclusion. We identified and classified 12 studies into three categories based on their focus: (i) those that directly assessed attention, (ii) those that directly manipulated participants' attention, and (iii) those that combined both a direct manipulation and assessment of attention. In all selected studies attention acted as a mechanism or mediator of the placebo/nocebo response, and was not considered a primary outcome of the placebo/nocebo manipulation. The synthesis of the included studies reveals that the role of attention in placebo and nocebo effects is still a topic of debate, marked by variations in how attention is conceptualized and measured. Results suggest that attention has significant clinical implications, particularly in optimizing therapeutic efficacy by directing patients' focus toward signs of healing and away from indicators of illness or distress. To advance our understanding, future research should explore these attentional mechanisms, in conjunction with neurophysiological correlates.

Effects of Ischemic Preconditioning on Sport-Specific Performance in Highly Trained Taekwondo Athletes.

Ischemic preconditioning (IPC), which involves episodes of blood flow restriction followed by reperfusion, has uncertain effects on athletes. Additionally, employing sports-specific tests that are highly familiar to athletes can enhance methodological rigor in determining IPC's effects on taekwondo performance. This study aimed to investigate IPC's influence on taekwondo athletes' performance through two studies. To induce occlusion in both studies, the cuff was inflated to an individualized occlusion pressure established for each athlete's lower limb, with four cycles of occlusion lasting five minutes each, alternated with five-minute reperfusion intervals. Both traditional frequentist statistics and Bayesian analysis were employed. In the first study, eleven high-level athletes were subjected to either IPC or a placebo (SHAM) procedure on both legs, followed by performing countermovement jumps (CMJs) and a specific taekwondo endurance test. However, no significant differences were observed in taekwondo endurance performance or CMJ between the IPC and SHAM conditions. The second study involved fourteen elite athletes who underwent the same IPC or SHAM conditions, performing CMJ and three bouts of the Multiple Frequency Speed of Kick test (FSKTmult) in three blocks, each separated by approximately thirty minutes. Again, the results indicated no significant differences in FSKTmult measures or CMJ performance between the two conditions. In conclusion, IPC did not significantly affect neuromuscular (in both studies), endurance (in the first study), or anaerobic (in the second study) performance in these taekwondo athletes.

Efficiency of interval hypoxia-hyperoxytherapy in the rehabilitation of patients with nonspecific musculosceletal low back pain: results of а randomized placebo-controlled study

BACKGROUND: Considering the high prevalence and social significance of nonspecific musculoskeletal lower back pain, the use of innovative non-drug rehabilitation methods, particularly interval hypoxia-hyperoxytherapy, is relevant. AIM: To evaluate the efficiency of the interval hypoxia-hyperoxytherapy in the complex medical rehabilitation of patients with nonspecific musculoskeletal lower back pain. MATERIALS AND METHODS: This randomized placebo-controlled study enrolled 62 patients (male, n=35; female n=27, aged 34–63 years) with nonspecific musculoskeletal lower back pain. All patients were randomized into two groups. The study group (n=34) received 10 procedures of hypoxia–hyperoxytherapy, and the comparison group (n=28) received 10 placebo procedures of breathing therapy. All groups underwent a 2-week standard rehabilitation program: 10 procedures of low-intensity laser therapy and low-frequency electrostatic therapy and 10 group sessions of physical exercises. The study group was breathing hypoxic (FiO2 13%–15%) and hyperoxic (FiO2 up to 40%) gas mixture through a mask in the interval mode using “ReOxy.” The duration of 1–4 procedures was 30 min and 5–10 procedures took 40 min. The placebo procedures were performed using masks with atmospheric air hole. Rehabilitation diagnosis by domains b28013, b7303, b7600, and d4500 of the International Classification of Functioning, Disability and Health (ICF), back pain and general health on a 100-mm visual analog scale, Lequesne index, 10-m walking test, Spielberger–Khanin reactive anxiety test, and Beck depression inventory were evaluated at baseline and week 2. RESULTS: After 2 weeks the values of the qualifiers of ICF domains significantly improved in the study group, back pain decreased by 65.2% (р 0.01), the Lequesne index by 76.1% (р 0.01), the 10-m walking test by 42.4% (р 0.05), the reactive anxiety level by 50.5% (р 0.01), and depression symptoms by 69.7% (р 0.01), whereas the general health improved by 71.2% (р 0.01), with statistically significant differences from the comparison group in all parameters (р 0.05). CONCLUSION: 2-week rehabilitation program, including interval hypoxia-hyperoxytherapy, reduces back pain and improves rehabilitation diagnosis based on the ICF, general health, functional status and psychoemotional state in patients with nonspecific musculoskeletal lower back pain.

Coronary sinus reducer for the treatment of refractory angina (ORBITA-COSMIC): a randomised, placebo-controlled trial

The coronary sinus reducer (CSR) is proposed to reduce angina in patients with stable coronary artery disease by improving myocardial perfusion. We aimed to measure its efficacy, compared with placebo, on myocardial ischaemia reduction and symptom improvement. ORBITA-COSMIC was a double-blind, randomised, placebo-controlled trial conducted at six UK hospitals. Patients aged 18 years or older with angina, stable coronary artery disease, ischaemia, and no further options for treatment were eligible. All patients completed a quantitative adenosine-stress perfusion cardiac magnetic resonance scan, symptom and quality-of-life questionnaires, and a treadmill exercise test before entering a 2-week symptom assessment phase, in which patients reported their angina symptoms using a smartphone application (ORBITA-app). Patients were randomly assigned (1:1) to receive either CSR or placebo. Both participants and investigators were masked to study assignment. After the CSR implantation or placebo procedure, patients entered a 6-month blinded follow-up phase in which they reported their daily symptoms in the ORBITA-app. At 6 months, all assessments were repeated. The primary outcome was myocardial blood flow in segments designated ischaemic at enrolment during the adenosine-stress perfusion cardiac magnetic resonance scan. The primary symptom outcome was the number of daily angina episodes. Analysis was done by intention-to-treat and followed Bayesian methodology. The study is registered with ClinicalTrials.gov, NCT04892537, and completed. Between May 26, 2021, and June 28, 2023, 61 patients were enrolled, of whom 51 (44 [86%] male; seven [14%] female) were randomly assigned to either the CSR group (n=25) or the placebo group (n=26). Of these, 50 patients were included in the intention-to-treat analysis (24 in the CSR group and 26 in the placebo group). 454 (57%) of 800 imaged cardiac segments were ischaemic at enrolment, with a median stress myocardial blood flow of 1·08 mL/min per g (IQR 0·77-1·41). Myocardial blood flow in ischaemic segments did not improve with CSR compared with placebo (difference 0·06 mL/min per g [95% CrI -0·09 to 0·20]; Pr(Benefit)=78·8%). The number of daily angina episodes was reduced with CSR compared with placebo (OR 1·40 [95% CrI 1·08 to 1·83]; Pr(Benefit)=99·4%). There were two CSR embolisation events in the CSR group, and no acute coronary syndrome events or deaths in either group. ORBITA-COSMIC found no evidence that the CSR improved transmural myocardial perfusion, but the CSR did improve angina compared with placebo. These findings provide evidence for the use of CSR as a further antianginal option for patients with stable coronary artery disease. Medical Research Council, Imperial College Healthcare Charity, National Institute for Health and Care Research Imperial Biomedical Research Centre, St Mary's Coronary Flow Trust, British Heart Foundation.

Warm-up plus verbal communications administered as placebo procedure during the training session improves running performance

The aim of this study was to investigate the effects on running performance of a within-session placebo procedure consisting of a conditioning treatment plus verbal communications. Twenty-six subjects were assigned to PLACEBO and CONTROL groups. Participants performed three sessions: Session 1-Cooper Test, Session 2-Baseline session and Session 3-Experimental session. During Session 2, participants performed a sprint-interval-training (SIT)-until-exhaustion preceded by a general warm-up, while in Session3 the SIT was preceded by a conditioning treatment (FIFA11+ warm-up), known to be effective in preventing injuries but not improving performance. Moreover, in Session3, only the PLACEBO group received verbal suggestions (before the warm-up) to influence participants' expectations about FIFA11+ effectiveness in improving performance, and deceptive feedback (during each SIT recovery bout) to increase the conditioning effect. To evaluate performance improvements, Running Time was chosen as a main outcome while to ensure participants reached exhaustion, physiological and metabolic responses were monitored. Total running distance (TRD) was also measured. Results showed that, Running Time and TRD significantly increased in the PLACEBO group whilst no differences in the CONTROL group were observed thus, suggesting the effectiveness of the within-session-placebo procedure in improving running performance. These findings shed a new light on the interaction between cognitive domain and performance, thus encouraging coaches to adopt this innovative method during the training protocol to enhance athletes’ performance. Moreover, this placebo procedure, not requiring additional time, tools or resources, could represent a more ecological approach that can be easily adopted in the field.

Preserving the placebo effect after disclosure: A new perspective on non-deceptive placebos.

The present study explores whether a particular style of placebo disclosure could serve as a tool to foster a renewed trust in one's own inherent resources and elicit a meaningful placebo effect. In a motor performance task, two placebo groups received inert transcutaneous electrical nerve stimulation (TENS) in each of four sessions along with information on its force-enhancing properties. Before the final session, one of the placebo groups was informed about the placebo, which was portrayed as a means to unleash an inherent potential. Along with force, we systematically monitored task-specific self-efficacy to test whether this variable would be differentially modulated in the two placebo groups. Compared to two control groups, placebo groups showed higher force and self-efficacy in the last session. No differences in self-efficacy were observed in the placebo groups even after revealing the placebo procedure, suggesting that the disclosure was effective in 'safeguarding' individuals' self-efficacy. These findings may have important implications, paving the way for the use of placebos that not only are ethically permissible but also support individuals' self-efficacy.

Management of chronic pain secondary to temporomandibular disorders: a systematic review and network meta-analysis of randomised trials

ObjectiveWe explored the comparative effectiveness of available therapies for chronic pain associated with temporomandibular disorders (TMD).DesignSystematic review and network meta-analysis of randomised clinical trials (RCTs).Data sourcesMEDLINE, EMBASE, CINAHL, CENTRAL, and...

A Placebo-Controlled Trial of Percutaneous Coronary Intervention for Stable Angina

BackgroundPercutaneous coronary intervention (PCI) is frequently performed to reduce the symptoms of stable angina. Whether PCI relieves angina more than a placebo procedure in patients who are not receiving antianginal medication remains unknown.MethodsWe conducted a double-blind, randomized, placebo-controlled trial of PCI in patients with stable angina. Patients stopped all antianginal medications and underwent a 2-week symptom assessment phase before randomization. Patients were then randomly assigned in a 1:1 ratio to undergo PCI or a placebo procedure and were followed for 12 weeks. The primary end point was the angina symptom score, which was calculated daily on the basis of the number of angina episodes that occurred on a given day, the number of antianginal medications prescribed on that day, and clinical events, including the occurrence of unblinding owing to unacceptable angina or acute coronary syndrome or death. Scores range from 0 to 79, with higher scores indicating worse health status with respect to angina.ResultsA total of 301 patients underwent randomization: 151 to the PCI group and 150 to the placebo group. The mean (±SD) age was 64±9 years, and 79% were men. Ischemia was present in one cardiac territory in 242 patients (80%), in two territories in 52 patients (17%), and in three territories in 7 patients (2%). In the target vessels, the median fractional flow reserve was 0.63 (interquartile range, 0.49 to 0.75), and the median instantaneous wave-free ratio was 0.78 (interquartile range, 0.55 to 0.87). At the 12-week follow-up, the mean angina symptom score was 2.9 in the PCI group and 5.6 in the placebo group (odds ratio, 2.21; 95% confidence interval, 1.41 to 3.47; P<0.001). One patient in the placebo group had unacceptable angina leading to unblinding. Acute coronary syndromes occurred in 4 patients in the PCI group and in 6 patients in the placebo group.ConclusionsAmong patients with stable angina who were receiving little or no antianginal medication and had objective evidence of ischemia, PCI resulted in a lower angina symptom score than a placebo procedure, indicating a better health status with respect to angina. (Funded by the National Institute for Health and Care Research Imperial Biomedical Research Centre and others; ORBITA-2 ClinicalTrials.gov number, NCT03742050.)

Adjunct remote ischemic conditioning to PCI in ST-segment elevation myocardial infraction patients: Systematic review and meta-analysis

Abstract Introduction ST-segment elevation myocardial infarction (STEMI) is the most dangerous presentation of the acute coronary syndrome (ACS). Throughout the last three decades, clinicians have been attempting to reduce the short and long-term major adverse cardiac events (MACE) associated with STEMI. Remote ischemic conditioning (RIC) is one of the new adjunctive modalities to PCI in treating STEMI patients whereby brief reversible episodes of ischemia and reperfusion are applied to the tissue (by alternative cycles of inflation and deflation of a blood pressure cuff on the upper or lower limb) confers global protection and renders remote tissues resistant to ischemia/reperfusion injury. This review aims to provide reliable evidence from published randomized controlled trials (RCTs) regarding whether RIC is beneficial for STEMI patients or not. Methods We followed the PRISMA guidelines during the preparation of this systematic review and meta-analysis. A computer literature search for (PubMed, Web of Science, Scopes, and Google Scholar) was carried out. We included RCT, comparing the remote ischemic conditioning, regardless of its timing of application to PCI, with either placebo or sham procedure, in terms of both short-term and long-term cardio protection. Outcomes of myocardial salvage index, myocardial infarction size, and left ventricular ejection fraction were pooled as the standardized mean difference between the two groups from baseline to endpoint. Results 11 RCTs (7151 patients), were included in this analysis. The overall effect on short-term outcomes, was in favor of PCI only in terms of myocardial salvage index(P value=0.04, 95% CI [0.00-0.08]), and left ventricular ejection fraction(P value=0.05, 95% CI [0.02,2.16]), while the adjunctive application of remote ischemic conditioning was beneficial in terms of: myocardial infarct size ( P value=0.004, 95% CI [-3.22,-0.62]). Regarding the long-term outcomes, the overall effect did not show any benefit in either of the two groups in terms of: major adverse cardiac and cerebrovascular events (MACCE) (P value=0.13, 95% CI [0.48,1.10]), hospitalization for heart failure (P value=1.00, 95% CI [0.83,1.20]), and cardiac death (P value=0.91, 95% CI [0.73,1.32]). Conclusion The adjunctive application of RIC to PCI during treatment of STEMI patients showed a beneficial effect only on short-term reduction of myocardial infarct size, nevertheless, it was not of benefit regarding the other short and long-term metrics of myocardial salvage and left ventricular function.

EMBIO trial study protocol: left gastric artery embolisation for weight loss in patients living with obesity with a BMI 35–50 kg/m2

IntroductionLeft gastric artery embolisation (LGAE) is a well-established treatment for major upper gastrointestinal (GI) bleeding when control is not established via upper GI endoscopy and recently has shown promising results...

Reduction in caffeine withdrawal after open-label decaffeinated coffee.

Withdrawal from addictive drugs can be reduced by administering placebo deceptively, but in the clinic it is unethical to deceive the patient. Open-label placebo effects have been observed across a range of psychophysiological phenomena, and may also apply to drug withdrawal. 24-hour abstinent heavy coffee drinkers (N = 61) rated their caffeine withdrawal symptoms before being allocated to one of three groups. The Deceptive group was given decaffeinated coffee (decaf) and told it was caffeinated, the Open-Label group given decaf and told it was decaf and the Control group given water and told it was water. After 45 min, caffeine withdrawal was measured again. All participants rated their expectancies of withdrawal reduction from caffeinated coffee, decaf and water prior to being randomised and the end of the study. There was a significant 9.5-point reduction in caffeine withdrawal in the Open-Label group (95% confidence interval (CI): 4.7, 14.3; p = 0.002), which was 8.6 points less than the Deceptive group (95%CI: 0.4, 16.8; p = 0.014) but 8.9 points greater than the Control group (95%CI: 0.6, 17.2; p = 0.012). Pre-randomisation, participants expected caffeinated coffee to reduce their withdrawal symptoms the most, followed by water and decaf, Pre-randomisation expectancy of withdrawal was only associated with amount of withdrawal reduction in the Deceptive group. It appears as if open-label placebo caffeine (i.e. decaf) can reduce caffeine withdrawal symptoms, even when people do not hold a conscious expectancy it will do so. There may be ways to integrate open-label placebo procedures into clinical interventions for drug dependence without violating informed consent.

Comparative Analysis of Sedative Efficacy of Dexmedetomidine and Midazolam in Pediatric Dental Practice: A Systematic Review and Meta-Analysis.

Children are particularly terrified of having dental treatment. They are physically resistant, frail, and unwilling to cooperate. This severe distress during the pre-operative phase could cause the dentist to have issues with behavior control. Additionally, it may make pediatric dental treatments less effective. In order to reduce anxiety and control behavior in children receiving dental care, sedation is a pharmacological management technique that supports the provision of effective and high-quality dental services. The aim is to compare and evaluate the efficacy of sedative agents like dexmedetomidine and midazolam in pediatric dental practice. A thorough review of the literature was conducted using electronic databases like “MEDLINE, PubMed, and CENTRAL (Cochrane Central Register of Controlled Trials), as well as the World Health Organization International Clinical Trials Registry Platform, www.clinicaltrials.gov, conference proceedings abstracts, a bibliography of pertinent references, and manual searches of journals, conferences, and books”. There were no restrictions on the language or the date of publication when searching the electronic databases.Randomized controlled trials were included which compared dexmedetomidine and midazolam in children up to 16 years of age subjected to dental treatment. Information on procedures, participants, interventions, outcome measures, and results were independently extracted by three review writers (TS, SL, and RO). Trial authors were contacted for papers that were confusing or lacking information. The risk of bias was evaluated for each study. We adhered to the Cochrane statistical recommendations. Three trials totaling 229 participants were included. All three studies were rated as having a low risk of bias, with none of them having a high or unclear risk. Meta-analysis was done for the available data for the primary outcomes like sedation level and recovery time. We searched for randomized controlled trials up to Jan 31, 2020. Participants are randomly assigned to an intervention or control group in randomized controlled trial research. While patients in the control group often get a placebo therapy or procedure, those in the interventional group receive the treatment being studied.We found three studies eligible to include in the review. One study evaluated 73 individuals who received general anesthesia for dental treatment. There were 72 and 84 individuals in the second and third investigations, respectively. All the participants of the three studies were divided randomly into two groups and were subjected to dexmedetomidine and midazolam as sedative agents. We gave the evidence an "extremely low certainty" rating. Because there are just three short trials with unusual parameters for comparison, the results are questionable. Overall, the results do not allow us to draw any firm conclusions. Three randomized controlled trials included in this systematic review reported data with varying conclusions; hence we recommend more randomized controlled trials to be conducted on this subject matter.

O102 We know about left gastric artery embolisation and will embio provide the next solution to treat obesity?

Abstract Introduction Left gastric artery embolisation (LGAE) is a minimally invasive procedure which has shown promising results for weight loss in recent studies and could play a key role as a treatment option in-between our current tier-3 and tier-4 services. Imperial College NHS Trust will sponsor the EMBIO trial, the first multi-centre double blinded randomised controlled trial comparing LGAE vs Placebo procedure to evaluate its efficacy on weight loss and obesity related comorbidities over a 12 month follow up period. Here, we perform a systematic review of the existing literature. Methods 9 studies were reviewed. Studies which investigated weight loss as a % +- Ghrelin % change at 3,6 and 12 months were included as these pre-defined time points correlate with the EMBIO protocol. 6 studies met our inclusion criteria, 5 single arm studies and 1 single blinded RCT. Results N=62 patients were included in our analysis. Mean weight loss reported was 8.5%, 8.8% and 10% at 3, 6 and 12 months respectively post LGAE. Ghrelin levels reduced by 36%, 16.2% and 16.5% at 3, 6 and 12 months respectively post LGAE. To date, the only reported adverse events recorded include superficial gastric erosions healed on endoscopy by day 90 and one case of subclinical pancreatitis. Conclusion LGAE potentially offers a day case procedure under local anaesthesia and sedation to treat obesity and its metabolic complications. The EMBIO trial will provide level 1 evidence to confirm if LGAE is a viable intervention for obesity and evaluate its safety profile. Take-home message Left gastric artery embolisation could be the perfect solution to treat obesity in between existing tier-3 and tier-4 treatments.

The Effectiveness of Intraosseous Basivertebral Nerve Radiofrequency Ablation for the Treatment of Vertebrogenic Low Back Pain: An Updated Systematic Review with Single-Arm Meta-analysis.

ObjectiveTo provide an estimate of the effectiveness of basivertebral nerve (BVN) radiofrequency ablation (RFA) to treat vertebrogenic low back pain (LBP).DesignSystematic review with single-arm meta-analysis.PopulationPersons ≥18 years of age with chronic LBP associated with type 1 or 2 Modic changes.InterventionIntraosseous BVN RFA.ComparisonSham, placebo procedure, active standard care treatment, or none.OutcomesThe proportion of patients treated with BVN RFA who reported ≥50% pain score improvement on a visual analog scale or numeric rating scale. The main secondary outcome was ≥15-point improvement in Oswestry Disability Index score.MethodsThree reviewers independently assessed articles published before December 6, 2021, in MEDLINE and Embase. The Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) framework was used to evaluate the overall quality of evidence.ResultsOf the 856 unique records screened, 12 publications met the inclusion criteria, representing six unique study populations, with 414 participants allocated to receive BVN RFA. Single-arm meta-analysis showed a success rate of 65% (95% confidence interval [CI] 51–78%) and 64% (95% CI 43–82%) for ≥50% pain relief at 6 and 12 months, respectively. Rates of ≥15-point Oswestry Disability Index score improvement were 75% (95% CI 63–86%) and 75% (95% CI 63–85%) at 6 and 12 months, respectively.ConclusionAccording to GRADE, there is moderate-quality evidence that BVN RFA effectively reduces pain and disability in most patients with vertebrogenic LBP. Further high-quality studies will likely improve our understanding of the effectiveness of this procedure.

General magnetic therapy and electrostatic field after radical surgical treatment of breast cancer at the 1st stage of medical rehabilitation

BACKGROUND: Various methods of physical therapy have been proposed for the rehabilitation of patients with breast cancer. However, a staged approach to prescribing physiotherapeutic factors in the early period after surgical treatment of breast cancer has not been developed enough.&#x0D; AIMS: to develop a staged approach to the appointment of physiotherapeutic factors at different times after surgical treatment of breast cancer.&#x0D; MATERIALS AND METHODS: Examination and treatment of 64 patients aged 30 to 70 years after surgical treatment for breast cancer were carried out. All patients underwent medical rehabilitation: individual exercise therapy, balanstherapy, sessions with a medical psychologist, course exposure to an alternating low-frequency electrostatic field and general magnetotherapy. The main group consisted of 33 patients who underwent a 2-stage course of medical rehabilitation: the 1st course on days 24 after the operation and the 2nd course after 11.5 months against the background of adjuvant radiation therapy. The control group 31 women, underwent physiotherapy placebo procedures.&#x0D; RESULTS: I was found that two-stage physical rehabilitation improves the quality of life, reduces swelling, increases the range of motion, decreases pain, decreases the number of postoperative complications, and shortens the duration of lymphorrhea.&#x0D; CONCLUSION: The inclusion of exposure to an alternating low-frequency electrostatic field and general magnetotherapy in the early stages (24 days) and 11.5 months after surgical treatment has broad functionality and allows you to obtain a pronounced functional and stable clinical result.

Сlinical Efficacy of Individually Dosed Intermittent Hypoxia-Hyperoxic Therapy in Osteoarthritis Patients with Post-Covid Syndrome

Aim. To evaluate the clinical efficiency of the individually dosed interval hypoxia-hyperoxic therapy in the medical rehabilitation of patients with osteoarthritis (OA), having post-COVID syndrome. Material and methods. 50 patients with OA (84% females, age of 43 to 68 years) where included in the randomized placebo-controlled study. Coronavirus infection COVID-19 were diagnosed from 12 to 26 weeks before the study. Patients had at least 6 symptoms of post-COVID syndrome. All patients were randomized into 3 groups. 18 patients of the study group received 10 hypoxia-hyperoxic therapy procedures, 15 comparison group patients – 10 placebo procedures, 14 control group patients – only standard rehabilitation. The study group patients were breathing hypoxic (FiO2 13–15%) and hyperoxic (FiO2 up to 40%) gas mixture through the mask in the interval mode using device ReOxy. The duration of 1–4 procedures was 30 min, 5–10 procedures – 40 min. The placebo procedures were performed using the mask with the atmospheric air hole. The standard rehabilitation program in all groups for 2 weeks included: 10 group sessions of physical exercises with elements of breathing exercises, 10 procedures of magnetic therapy for joints, 10 sodium chloride baths. Joint pain and general health on 100-mm visual analog scale, Lequesne and WOMAC indexes, Spielberger-Khanin reactive anxiety test, Beck depression inventory and breathlessness on Modified Borg scale were evaluated at baseline (control point T0) and at 2 weeks (control point T1). Results and discussion. After 2 weeks (T1) in the study group, pain decreased by 51.4% (p &lt; 0.01), Lequesne index – by 34.8% (p &lt; 0.05), WOMAC – by 44.7% (p &lt; 0.05), reactive anxiety level – by 23.7% (p &lt; 0.05), depression symptoms – by 52.9% (p &lt; 0.01), breathlessness – by 71.2% (p &lt; 0.01), general health improved by 52.1% (р &lt; 0.01). In the study group, there were statistically significant differences from the control group in all parameters (р &lt; 0.05) and from the comparison group in most indicators (р &lt; 0.05), excluding the Lequesne index. These results are consistent with the data of modern studies of efficiency of hypoxic conditioning. Conclusion. 2-week rehabilitation program, including interval hypoxia-hyperoxic therapy, reduces pain, breathlessness, depression and reactive anxiety symptoms, improves general health and functional status in patients with OA, having post-COVID syndrome.

Arthroscopic surgery for degenerative knee disease (osteoarthritis including degenerative meniscal tears).

Arthroscopic surgery for degenerative knee disease (osteoarthritis including degenerative meniscal tears).